PET/MR Imaging for Cardiac Arrhythmias

Overseen By Marc Normandin

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Disqualifiers: Heart disease, Arrhythmia, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Varies per patient

34 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is performed to assess if PET-MR imaging can improve treatment of patients with irregular heart rate and heart failure. Heart failure occurs when the heart muscle is too weak to do his work correctly. Irregular heart rate can be related to numerous diseases. One category of irregular heart rate is called ventricular arrhythmia. It is often seen in patients who have had a heart attack. This type of arrhythmia can be dangerous and can cause sudden death. To prevent these arrhythmias, doctors can perform procedures that burn the source of arrhythmia in the heart muscle. This is called ablation. Unfortunately, ablation does not fix the problem in 100% of patients and some will still have the arrhythmia requiring repeated procedure. The purpose of this study is to find new ways of guiding the doctors performing ablation, hoping to improve the success rate of the procedure.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What data supports the effectiveness of the treatment 18F-TPP for cardiac arrhythmias?

The research highlights the potential of PET/MR imaging in diagnosing and managing cardiac arrhythmias by assessing heart function and structure, which can help in understanding the effectiveness of treatments like 18F-TPP. PET imaging, part of the PET/MR approach, is particularly useful in evaluating heart conditions that may lead to arrhythmias, suggesting that 18F-TPP could be effective in this context. ^{1 2 3 4 5}

Is PET/MR Imaging for Cardiac Arrhythmias safe for humans?

The research articles discuss the safety of MRI in various contexts, including patients with cardiac devices and children, but do not specifically address the safety of PET/MR Imaging or 18F-TPP for cardiac arrhythmias. However, MRI is generally considered a safe imaging technique, with specific protocols to minimize risks, especially in patients with certain devices. ^{6 7 8 9 10}

How does PET/MR imaging for cardiac arrhythmias differ from other treatments?

PET/MR imaging is unique because it combines two advanced imaging techniques to provide a comprehensive view of the heart's structure and function, which helps in diagnosing and managing cardiac arrhythmias. This approach allows for the assessment of myocardial perfusion (blood flow in the heart muscle), inflammation, and sympathetic innervation, offering insights that are not possible with traditional treatments. ^{1 4 11 12 13}

Eligibility Criteria

This trial is for adults aged 21-80 with a history of scar-mediated ventricular arrhythmia who are scheduled for ablation therapy. They must be able to consent and have no structural heart disease, MRI/PET contraindications, severe kidney issues, diabetes, lupus, or certain other conditions. Pregnant or lactating women cannot participate.

Inclusion Criteria

I am between 21 and 80 years old.

Subjects must provide informed consent prior to study procedures

I am scheduled for a procedure to treat irregular heartbeats caused by scar tissue.

Exclusion Criteria

I do not have any health conditions or devices that prevent MRI or PET scans.

I have had irregular heartbeats from the lower chambers of my heart.

I have a heart condition like a previous heart attack.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo EAM-guided catheter ablation and PET-MR imaging to assess treatment improvement

Varies per patient

Follow-up

Participants are monitored for safety and effectiveness after ablation treatment

5 years

Repeat Ablation (if necessary)

Participants with recurrent ventricular arrhythmia undergo a second imaging session and repeated ablation

Varies per patient

Treatment Details

Interventions

• 18F-TPP

Trial Overview The study tests if PET-MR imaging can help doctors perform ablation more successfully in patients with irregular heart rates due to ventricular arrhythmias. The goal is to improve the procedure's success rate and reduce the need for repeat treatments.

Participant Groups

Group I: Treatment Failure Experimental Treatment 1 Intervention

A subset of the Arrhythmia cohort, this group will undergo a second imaging session. This subset corresponds to patients from the Arrhythmia cohort presenting with recurrent ventricular arrhythmia following initial EAM-guided catheter ablation and requiring repeated ablation. It is estimated that 30% of the Arrhythmia cohort patients will require repeat ablation based on rate of repeat ablation procedures at MGH. T

Group II: Arrhythmia Experimental Treatment 1 Intervention

This cohort consist of patients with history of recurrent VT and scheduled for EAM-guided catheter ablation as part of their clinical treatment

Group III: Control Active Control 1 Intervention

Normal subjects without history of cardiac disease or arrhythmia

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

Cardiovascular magnetic resonance (MR) is a safe, non-invasive imaging technique that is the gold standard for assessing heart anatomy and function, but it is important to understand the safety and contraindications of various metal and electronic devices in patients undergoing MR.

The review highlights potential factors affecting image quality and patient comfort, such as arrhythmias and claustrophobia, and discusses the safety and side effects of gadolinium-based contrast agents used in MR imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications. Barison, A., Baritussio, A., Cipriani, A., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Potential Role of PET in Assessing Ventricular Arrhythmias. [2019]

2. Germany pubmed.ncbi.nlm.nih.gov

Cardiovascular hybrid imaging using PET/MRI. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Structural and Physiological Imaging to Predict the Risk of Lethal Ventricular Arrhythmias and Sudden Death. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Diagnosis of cardiac abnormalities in patients with nonischemic tachyarrhythmias: additional value of MR imaging. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Applications of PET-MR Imaging in Cardiovascular Disorders. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Free breathing cardiac real-time cine MR without ECG triggering. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of MRIs in patients with pacemakers and defibrillators. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Myocardial Stress Perfusion MRI Using Regadenoson: A Weight-based Approach in Infants and Young Children. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

MRI in pediatric and congenital heart disease patients with CIEDs and epicardial or abandoned leads. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance: What clinicians should know about safety and contraindications. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Applications of Cardiac MR Imaging in Electrophysiology: Current Status and Future Needs. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Value of cardiac MRI to evaluate ischemia-related ventricular arrhythmia substrates. [2015]

13. England pubmed.ncbi.nlm.nih.gov

Feasibility of real-time MR thermal dose mapping for predicting radiofrequency ablation outcome in the myocardium in vivo. [2022]